EAA/Therapy for Treating Children With ADHD
Equine-Assisted Activities and Therapy for Treating Children With Attention-Deficit/Hyperactivity Disorder
1 other identifier
interventional
46
1 country
1
Brief Summary
The aim of this study is 1) to investigate clinical effects of equine-assisted activities and therapy (EAA/T) for treating attention-deficit/hyperactivity disorder (ADHD) and 2) to compare the clinical effect of EAA/T and drug therapy in children 6-13-years-of-age. This study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of EAA/T. Forty six subjects will be enrolled and various clinical tests will be administered at baseline and after EAA/T or drug therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 24, 2015
CompletedFirst Posted
Study publicly available on registry
June 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 26, 2015
June 1, 2015
2.6 years
June 24, 2015
June 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
chane of ARS-I score
change of Investigator-administered ADHD-Rating Scale (ARS-I) after Equine-Assisted Therapy
change measures (baseline and 12 weeks)
Study Arms (2)
EAA/T
EXPERIMENTALEAA/TEquine-Assisted Activities and Therapy) bi-weekly for 12eeks
Drugs
ACTIVE COMPARATORMethylphenidate or Atomoxetine
Interventions
bi-weekly for 12weeks
dosage adjustment according to clinical effectiveness, QD for 12weeks
dosage adjustment according to clinical effectiveness, QD or BID, for 12weeks
Eligibility Criteria
You may qualify if:
- a diagnosis of ADHD according to Diagnostic and Statistical Manual-IV-Text Version(DSM-IV-TR) and Korean Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Life¬time Version (K-SADS-PL)
You may not qualify if:
- (1) a learning disorder or an intelligence quotient (IQ) measured by the Korean Wechsler Intelligence Scale for Children-IV (K-WISC-IV) \< 70, (2) significant medical condition, schizophrenia or other psychotic disorder, bipolar disorder, a history of alcohol or drug dependence, neurologic disorders, epilepsy, and organic mental disorders; (3) a major depressive disorder that required pharmacotherapy; (4) significant suicidal ideation; (5) a Tourette's disorder or obsessive-compulsive disorder that required pharmacotherapy; (6) use of methylphenidate or atomoxetine within 90 days of baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Samsung Electronicscollaborator
Study Sites (1)
Yoo-Sook Joung
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoo-Sook Joung, M.D.,Ph.D.
Department of Psychiatry, Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2015
First Posted
June 26, 2015
Study Start
January 1, 2013
Primary Completion
August 1, 2015
Study Completion
December 1, 2015
Last Updated
June 26, 2015
Record last verified: 2015-06